In the past few years, there has been a significant increase in the number of diagnostic and therapeutic procedures using monorail-type catheters. Monorail-type catheters, such as those disclosed in U.S. Pat. No. 4,762,129 issued to Bonzel, are used in angioplasty operations for dilating a region of stenosis in the coronary arteries. Before any angioplasty operation commences, it is typical for a physician to prepare the catheter after it is removed from its package and prior to its use.
Preparation of a monorail catheter prior to use usually involves flushing the guidewire lumen with a saline solution to improve the lubricity of the lumen, and therefore the tractability of a catheter over an in-situ guidewire. This flushing procedure also serves to cleanse the guidewire lumen of any contaminants introduced during the manufacture and packaging of the catheter.
Monorail catheters, unlike common over-the-wire catheters, are not manufactured with an integral luer fitting on the proximal end of the guidewire lumen and are usually packaged with a solid stylet inserted in the guidewire lumen to maintain its patency during shipping and storage. To prepare the catheter, the physician will typically remove the solid stylet that is inserted in the guidewire lumen and then insert the tip of a hypodermic needle of a syringe filled with fluid, into the proximal or distal end of the guidewire lumen. Care and time are required to prevent perforating the inflation lumen of the catheter during the insertion process. Once the hypodermic needle is positioned inside the guidewire lumen, the physician then flushes the appropriate cleaning/lubricating fluid through the guidewire lumen.
A major difficulty with this time consuming practice is the cumbersome handling of the typically flimsy catheter while performing the lumen flushing procedure. Moreover, accidental puncturing of the inflation lumen occurs oftentimes when the physician attempts to insert the tip of the hypodermic needle into the adjacent guidewire lumen during the flushing operation. Once such damage occurs, the catheter is unusable because it is unsafe, and must be discarded. Unfortunately, coronary catheters are quite expensive, costing several hundreds of dollars each. The cost of catheters represents a significant portion of the overall cost of the angioplasty procedure, and avoiding unnecessary damage to the catheter would be a great help in controlling the spiraling cost of medical procedures utilizing catheters.
Thus, there is a need for a device and method which facilitates the preparation and safe flushing of the guidewire lumen of a catheter while preventing accidental damage to the catheter.
Accordingly, it is an object of the present invention to provide a surgical tool for facilitating the handling of a catheter during its preparation for use.
It is another object of the present invention to provide a surgical tool that facilitates the safe flushing or lubricating of a catheter lumen while preventing accidental damage that may be caused by a misplaced hypodermic needle.
It is yet another object of the invention to provide a tool which will maintain the catheter shaft substantially stationary while its being flushed.
It is still another object to provide a catheter flushing tool that is simple in design and use, and economical to manufacture.
The foregoing objects and advantages of the invention are illustrative of those which can be achieved by the present invention and are not intended to be exhaustive or limiting of the possible advantages which can be realized. Thus, these and other objects and advantages of the invention will be apparent from the description herein or can be learned from practicing the invention, both as embodied herein or as modified in view of any variations which may be apparent to those skilled in the art. Accordingly, the present invention resides in the novel parts, constructions, arrangements, combinations and improvements herein shown and described.